DIN EN ISO 10328-2016 Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO 10328 2016) German version EN ISO 10328 2016《修复术 假下肢的结构试验 要求和试验.pdf

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1、December 2016 English price group 35No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.180.10!%n6“2597519www.din.de

2、DIN EN ISO 10328Prosthetics Structural testing of lowerlimb prostheses Requirements and test methods (ISO 10328:2016);English version EN ISO 10328:2016,English translation of DIN EN ISO 10328:2016-12Prothetik Prfung der Struktur von Prothesen der unteren Gliedmaen Anforderungen und Prfverfahren (ISO

3、 10328:2016);Englische Fassung EN ISO 10328:2016,Englische bersetzung von DIN EN ISO 10328:2016-12Prothses Essais portant sur la structure des prothses de membres infrieurs Exigences et mthodes dessai (ISO 10328:2016);Version anglaise EN ISO 10328:2016,Traduction anglaise de DIN EN ISO 10328:2016-12

4、SupersedesDIN EN ISO 10328:200704www.beuth.deDocument comprises 154 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.12.16 DIN EN ISO 10328:2016-12 2 A comma is used as the decimal marker. National foreword This document (EN ISO

5、 10328:2016) has been prepared by Technical Committee ISO/TC 168 “Prosthetics and orthotics” in collaboration with Technical Committee CEN/TC 293 “Assistive products for persons with disability” (Secretariat: SIS, Sweden), in accordance with the Agreement on technical cooperation between ISO and CEN

6、 (Vienna Agreement). The responsible German body involved in its preparation was DIN-Normenausschuss Feinmechanik und Optik (DIN Standards Committee Optics and Precision Mechanics), Working Committee NA 027-02-03 AA Orthopdietechnik. EN ISO 10 23 8:2016, together with European Standards EN ISO 22675

7、:2016 and EN ISO 22523:2006, gives an overview of specifications which provide the means of applying the essential requirements of Annex I of the EU Medical Devices Directive on medical devices to external limb prostheses and external orthoses (the Directive has been implemented in Germany by the Ge

8、rman Medical Devices Act (Medizinproduktegesetz MPG) see also Annex G of this standard). EN ISO 10328:2016 specifies methods of testing the proof, ultimate and fatigue strength of external lower limb prostheses and their components, as well as static strength in torsion and security against slippage

9、 of clamped components. In Clause 5 a specific lower limb prosthetic device/structure is described that has the strength to sustain the loads occurring during use by amputees in the manner intended. The following special safety concept shall apply: a) the device/structure shall comply with the requi

10、rements specified in this standard for a specific test loading level and b) the device/structure shall only be used in accordance with the body mass limit for amputees as specified by the manufacturer in consideration of the intended use of that ankle-foot device or foot unit. Compliance with the co

11、nditions specified in a) and b) by classification and designation as well as by labelling of the device/structure is dealt with in Clauses 20 and 21. Since DIN EN ISO 10328:2016 is a harmonized standard, lower limb prostheses and components as in this standard can be assumed to meet the relevant sti

12、pulations of the German Medical Devices Act (MPG) (the so-called “presumption of conformity”), thus considerably simplifying CE conformity marking of these products. The present standard and EN ISO 22675:2016 both specify methods of testing prosthetic ankle-foot devices and foot units. A transition

13、period will be established during which both test methods are valid (see the introductions to these two standards). The DIN Standards corresponding to the International Standards referred to in Clause 2 of this standard are as follows: ISO 22523:2006 DIN EN ISO 22523:2007-04 ISO 22675:2016 DIN EN IS

14、O 22675:2016-12 DIN EN ISO 10328:2016-12 3 Amendments This standard differs from DIN EN ISO 10328:2007-04 as follows: a) test loading levels P7 and P8 have been introduced in Tables B.1, B.2, B.3, B.4, D.1, D.2 and D.3, and the clauses referring to these tables have been updated. Additional informat

15、ion on P7 and P8 is given in Annex B.1; b) Table 9 has been revised; c) Annex D has been changed from informative to normative. Previous editions DIN EN ISO 10328: 2007-04 DIN EN ISO 10328:2016-12 4 National Annex NA (informative) Bibliography DIN EN ISO 22523:2007-04, External limb prostheses and e

16、xternal orthoses Requirements and test methods (ISO 22523:2006) DIN EN ISO 22675:2016-12, Prosthetics Testing of ankle-foot devices and foot units Requirements and test methods (ISO 22675:2016) EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10328 June 2016 ICS 11.040.40 Supersedes EN ISO 1

17、0328:2006English Version Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO 10328:2016) Prothses - Essais portant sur la structure des prothses de membres infrieurs - Exigences et mthodes dessai (ISO 10328:2016) Prothetik - Prfung der Struktur von Prothese

18、n der unteren Gliedmaen - Anforderungen und Prfverfahren (ISO 10328:2016) This European Standard was approved by CEN on 12 May 2016. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national sta

19、ndard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in

20、any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Re

21、public, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPE

22、AN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2016 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 10328:2016 EFo

23、reword . 9Introduction 101 Scope 112 Normative references . 113 Terms and definitions 124 Designations and symbols of test forces and moments 125 Strength and related performance requirements and conditions of use . 136 Coordinate systems and test configurations 156.1 General 156.2 Axes of coordinat

24、e systems . 156.3 Reference planes 156.3.1 General. 156.3.2 Top reference plane, T 156.3.3 Knee reference plane, K 156.3.4 Ankle reference plane, A 166.3.5 Bottom reference plane, B 166.4 Reference points . 176.5 Test force . 186.6 Load line 186.7 Longitudinal axis of the foot and effective joint ce

25、ntres and centrelines 186.7.1 General. 186.7.2 Longitudinal axis of the foot . 186.7.3 Effective ankle-joint centre 186.7.4 Effective ankle-joint centreline 206.7.5 Effective knee-joint centreline 206.7.6 Effective knee-joint centre 216.8 Reference distances . 216.8.1 Offsets . 216.8.2 Combined offs

26、ets 216.8.3 Effective lever arms LAand LK6.8.4 Distance LBT7 Test loading conditions and test loading levels .217.1 Test loading conditions . 217.1.1 General. 217.1.2 Test loading conditions of principal structural tests .227.1.3 Test loading conditions of separate structural tests 227.2 Test loadin

27、g levels . 228 Values of test loads, dimensions and cycles 239 Compliance 309.1 General 309.2 Selection of tests required to claim compliance with this International Standard .319.3 Arrangements for tests on samples of prosthetic structures including ankle-foot devices or foot units, required to cla

28、im compliance with this International Standard .319.3.1 General. 319.3.2 Particular arrangements concerning the ankle-foot device or foot unit 319.3.3 Particular arrangements and requirements concerning the part required to connect the ankle-foot device or foot unit to the remainder of the prostheti

29、c structure .31Contents PageEuropean foreword 3 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC 4 .DIN EN ISO 10328:2016-12 EN ISO 10328:2016 (E)221219.5.1 General. 329.5.2 Restriction 329.6 Testing at particular test loadin

30、g levels not specified in this International Standard .3310 Test samples .3510.1 Selection of test samples . 3510.1.1 General. 3510.1.2 Selection of ankle-foot devices and foot units of appropriate size of foot 3610.2 Types of test samples . 3710.2.1 Complete structure .3710.2.2 Partial structure 39

31、10.2.3 Any other structure 3910.3 Preparation of test samples 3910.4 Identification of test samples 4010.5 Alignment of test samples 4110.5.1 Test samples for principal tests and separate tests on knee locks 4110.5.2 Test samples for separate tests on ankle-foot devices and foot units .4110.5.3 Test

32、 samples for separate static ultimate strength tests in maximum knee flexion for knee joints and associated parts 4110.5.4 Test samples for separate tests on knee locks .4210.6 Worst-case alignment position of test samples .4211 Responsibility for test preparation 4312 Test submission document .4412

33、.1 General requirements 4412.2 Information required for test samples 4512.2.1 All test samples 4512.2.2 Test samples for tests on ankle-foot devices and foot units 4512.2.3 Test samples for static ultimate strength tests in maximum knee flexion for knee joints and associated parts 4512.3 Information

34、 required for tests 4512.3.1 General. 4512.3.2 For all tests . 4512.3.3 For static tests in torsion and on ankle-foot devices and foot units .4612.3.4 For static ultimate strength tests 4612.3.5 For cyclic tests .4612.3.6 For tests in torsion 4612.3.7 For tests on ankle-foot devices and foot units .

35、4613 Equipment 4713.1 General 4713.2 Equipment for the principal tests specified in 16.2 and 16.3 4713.2.1 End attachments .4713.2.2 Jig (optional) .4913.2.3 Test equipment .5013.3 Equipment for the separate static test in torsion specified in 17.1 5213.3.1 Test equipment .5213.4 Equipment for the s

36、eparate tests on ankle-foot devices and foot units specified in 17.2 5213.4.1 Test equipment .5213.5 Equipment for the separate static ultimate strength test in maximum knee flexion for knee joints and associated parts specified in 17.3 .5613.5.1 Extension pieces 5613.5.2 Test equipment to perform s

37、tatic compression loading (Compression testing machine or other equipment).5613.6 Equipment for the separate tests on knee locks specified in 17.4 5613.6.1 End attachments .569.5 Multiple use of test samples . 32DIN EN ISO 10328:2016-12 EN ISO 10328:2016 (E)39.4 Number of tests and test samples requ

38、ired to claim compliance with this International Standard 3214.1 General 5714.2 Accuracy of equipment . 5714.3 Accuracy of procedure . 5715 Test principles 5815.1 General 5815.2 Static test procedure . 5815.3 Cyclic test procedure . 5816 Test procedures Principal structural tests.5816.1 Test loading

39、 requirements . 5816.1.1 Preparation for test loading 5816.1.2 Application of test loading 5816.2 Principal static test procedure . 6016.2.1 Principal static proof test 6016.2.2 Principal static ultimate strength test 6516.3 Principal cyclic test procedure . 6916.3.1 General requirements .6916.3.2 T

40、est method . 6916.3.3 Performance requirements 7316.3.4 Compliance conditions 7417 Test procedures Separate structural tests .7817.1 Separate static test in torsion 7817.1.1 General. 7817.1.2 Purpose of test 7817.1.3 Test method . 7817.1.4 Performance requirements 8017.1.5 Compliance conditions 8017

41、.2 Separate tests on ankle-foot devices and foot units 8217.2.1 General. 8217.2.2 Purpose of tests8217.2.3 Separate static proof test for ankle-foot devices and foot units 8217.2.4 Separate static ultimate strength test for ankle-foot devices and foot units 8617.2.5 Separate cyclic test for ankle-fo

42、ot devices and foot units .9117.3 Separate static ultimate strength test in maximum knee flexion for knee joints and associated parts. 9617.3.1 General. 9617.3.2 Purpose of test 9617.3.3 Applicability of the test to specific test samples .9617.3.4 Test method . 9717.3.5 Performance requirement 9817.

43、3.6 Compliance conditions 9817.4 Separate tests on knee locks 9917.4.1 General. 9917.4.2 Purpose of tests10017.4.3 Separate static proof test for knee locks 10017.4.4 Separate static ultimate strength test for knee locks 10417.4.5 Separate cyclic test for knee locks . 10618 Test laboratory/facility

44、log . 11518.1 General requirements .11518.2 Specific requirements .11519 Test report 11519.1 General requirements .11519.2 Specific requirements .11619.3 Options .11614 Accuracy .57DIN EN ISO 10328:2016-12 EN ISO 10328:2016 (E)413.6.2 Jig (optional) .5613.6.3 Test equipment .5620.2 Examples of class

45、ification and designation 11621 Labelling . 11721.1 General .11721.2 Use of mark “*)” and warning symbol .11821.3 Examples of label layout .11821.4 Label placement .118Annex A (informative) Description of internal loads and their effects . 120Annex B (informative) Reference data for the specificatio

46、n of test loading conditions and test loading levels of principal cyclic tests 124Annex C (informative) Guidance on the application of an alternative static ultimate strength test . 128Annex D (normative) Guidance on the application of an additional test loading levels P6, P7 and P8 . 129Annex E (in

47、formative) Summary of the records to be entered in the test laboratory/facility log 132Annex F (informative) Background information on the loading profiles generated by test equipment according to 13.4.1.2 for separate cyclic tests for ankle-foot devices and foot units according to 17.2.5.1 147Annex

48、 G (informative) Reference to the essential principles of safety and performance of medical devices according to ISO/TR 16142 . 149Bibliography . 150DIN EN ISO 10328:2016-12 EN ISO 10328:2016 (E)520 Classification and designation 11620.1 General .116European foreword This document (EN ISO 10328:2016

49、) has been prepared by Technical Committee ISO/TC 168 “ Prosthetics and orthoticsa“ in collaboration with Technical Committee CEN/TC 293 “Assistive products for persons with disability” the secretariat of which is held by SIS. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by December 2016, and conflicting national standards shall be withdrawn at the latest by